MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-17 for ZOOBY VARNISH 999351 manufactured by Young Dental Manufacturing Co 1, Llc..
[38373686]
The patient and the hygienist both said the varnish was burning the inside of their mouths. They immediately washed out their mouths and then reported they were okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00003 |
| MDR Report Key | 5441973 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-17 |
| Date of Report | 2016-01-21 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2016-02-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH MOORE |
| Manufacturer Street | 13705 SHORELINE CT. E. |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143440010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOBY VARNISH |
| Generic Name | VARNISH |
| Product Code | LBH |
| Date Received | 2016-02-17 |
| Model Number | 999351 |
| Catalog Number | 999351 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING CO 1, LLC. |
| Manufacturer Address | 13705 SHORELINE CT. E. EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-17 |